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Exercise Program for Colorectal Older Patients

NCT05448846 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2026-01-08

No results posted yet for this study

Summary

The Exercise for COlorectal OLder patients (ECOOL program) is randomized controlled trial to assess the effects of an exercise program on physical function and health-related quality of life of patients 75 years and older with colorectal cancer undergoing surgery. ECOOL is a multicomponent home-based exercise intervention focused on the development of strength, balance, gait ability and inspiratory muscle function of older patients who receive weekly telephone follow-up from cancer diagnosis to 3 months after surgery. The investigators expect that ECOOL program will improve physical function and health-related quality of life of older patients 3 months after surgery and to maintain these benefits up to 6 months after surgery compared with the control group receiving usual care.

Conditions

  • Colorectal Neoplasms
  • Aged

Interventions

PROCEDURE

Enhanced Recovery After Surgery

ERAS protocol includes preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens and early mobilization.

BEHAVIORAL

Home-based multicomponent exercise program (EXE)

Home-based multicomponent exercise program: A) Strength and balance (20 to 40 minutes, 2 days/week): * Chair sit to stand exercise \| 1 to 3 sets completing repetitions until rating 5 to 8 in the Rated of Perceived Exertion, 0-10 scale (RPE). * Seated curl to press exercise \| 1 to 3 sets completing repetitions until rating 5 to 8 RPE. * Monopodal balance \| 1 to 3 sets with progressive time targets up to 60-second for each leg. B) Gait (at least 30 minutes at an intensity that allows for comfortable conversation, 2 days/week on separate days from strength and balance exercise) C) Inspiratory Muscle Training: 30 inspirations at 40% of maximal inspiratory pressure through a Power Breathe device, 2 times per day)

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Hospital General Universitario Gregorio Marañon

    lead OTHER

Principal Investigators

  • Jose Antonio Serra-Rexach, PhD, MD · HGU Gregorio Marañon

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-08
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05448846 on ClinicalTrials.gov